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| Name | Class |
|---|---|
| Sibel Health Inc. | INDUSTRY |
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The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).
The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST) for the diagnosis of moderate to severe OSA.
Other study objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANNE Sleep | Experimental | After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANNE Sleep | Device | ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. | To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea. | 4 nights |
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Inclusion Criteria:
22 years old.
Exclusion Criteria:
-An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection based on the opinion of the investigator, this includes but is not limited to: A. Significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% B. Respiratory muscle weakness due to a neuromuscular condition C. Awake hypoventilation or suspicion of sleep related hypoventilation D. Chronic opioid medication use E. History of stroke F. History of severe insomnia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36692166 | Derived | Walter J, Lee JY, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Yu L, Park J, Zhang M, Coughlin S, Serao A, Lee J, Buban A, Bae M, Edel C, Toloui O, Rangel SM, Power T, Xu S. A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments. J Clin Sleep Med. 2023 May 1;19(5):865-872. doi: 10.5664/jcsm.10432. |
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Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.
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Thirty-eight participants consented to the study and thirty participants started the study. Eight participants decided not to participate before any study procedures or were lost to follow-up after the consent process.
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| ID | Title | Description |
|---|---|---|
| FG000 | ANNE Sleep | After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone. ANNE Sleep: ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ANNE Sleep | After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone. ANNE Sleep: ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea. | To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea. | Posted | Number | 95% Confidence Interval | percent agreement | 4 nights |
|
Four nights
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANNE Sleep | After consent, subjects will wear the ANNE Sleep system with HST for 1 night and 3 nights with ANNE sleep system alone. ANNE Sleep: ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuai Xu | Northwestern University | 312-695-8106 | stevexu@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2022 | Mar 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2022 | Mar 27, 2023 | ICF_001.pdf |
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Patients will use ANNE Sleep system with Home Sleep Testing (HST) during one night followed by three subsequent nights with the ANNE Sleep system alone.
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| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants could indicate more than one race. | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Epworth Sleepiness Scale | Epworth Sleepiness Scale is a self-administered questionnaire to provide a measurement of the subject's general level of daytime sleepiness. Subject rate on a scale of 1-3 for each of the eight questions: 0= would never doze, 1=slight chance of dozing, 2=moderate change of dozing, and 3=high chance of dozing. The answers are added together to give a final score from 0 to 24, 24 being the highest level of daytime sleepiness. Scores of 16 or higher indicates a high level of daytime sleepiness. | Median | Inter-Quartile Range | units on a scale |
|
| Hypertension | Count of Participants | Participants |
|
| Type II Diabetes | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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